Intra-uterine contraceptive devices

ABSTRACT

An intra-uterine contraceptive device consisting of a plurality of straight elements connected to one another in divergent relation by resilient joints, with the end elements being of a greater length than the intermediate elements, and having their free ends spaced from one another a distance not greater than their connected ends. In one form the device comprises a folded leaf spring. In another form, the device comprises a flattened spiral with the two end elements interengaged with the elements to which they are connected, either by interengagement of the free end of the end elements against the adjacent joints of their adjacent element, or by passing a confining sleeve over each end element and its adjacent element, to thereby impart to the device a tapered shape. The devices serve as carriers for slow-diffusing drugs into the uterus, as by attaching a pocket for the drugs to the confining sleeve.

United States Patent 1191 Chaft [4 1 Apr. 30, 1974 1 INTRA-UTERINE CONTRACEPTIVE DEVICES [76] Inventor: Marc E. Chaft, 8 Tripplet Rd.,

Somerset, NJ. 08873 [22] Filed: July 5, 1968 [21] App]. No.: 742,984

Related US. Application Data [63] Continuation-in-part of Ser. No. 511,701, Dec. 12,

1965, Pat. N0. 3,410,265.

FOREIGN PATENTS OR APPLICATIONS 150,127 4/1904 Germany.... 128/130 Primary Examiner-Kyle L. Howell Attorney, Agent, or Firm-Gottlieb, Rackman, Reisman & Kirsch 7] ABSTRACT An intra-uterine contraceptive device consisting of a plurality of straight elements connected to one another in divergent relation by resilient joints, with the end elements being of a greater length than the intermediate elements, and having their free ends spaced from one another a distance not greater than their connected ends. In one form the device comprises a folded leaf spring. In another form, the device comprises a flattened spiral with the two end elements interengaged with the elements to which they are connected, either by interengagement of the free end of the end elements against the adjacent joints of their adjacent element, or by passing a confining sleeve over each end element and its adjacent element, to thereby impart to the device a tapered shape. The devices serve as carriers for slow-diffusing drugs into the uterus, as by attaching a pocket for the drugs to the confining sleeve.

5 Claims, 6 Drawing Figures PATENTED APR 30 I974 FQIGQI R 0 T N E V N MARC E. CHAFT The presentinvention relates to means and'methods for inducing contraception per uterus, and .is a continuation-in-part of my application Ser. No. 511,701,

have the elements parallel and substantially contacting one another, for easy insertion into the uterus, with its narrower end foremost.

The device described in my said co-pending application possesses numerous advantages over similar articles of the prior art, as fully set forth therein. Suchadvantages include a capability of quick and easy insertion without the need for dilation of the cervical canal and witha minimum of effort; capability of accurate positioning within the fundus of the uterine cavity; retention of shape within the uterine cavity for prolonged periods of time; increased safety within the uterine cavityagainst damage or other adverse effect on the walls of the uterine cavity; easy removal from the uterine cavity without need for undue dilation or causing injury to the uterine passage; and retention, within the uterine cavity againstdischarge by the very activity of the muscles of the walls of theuterine cavity which would tend to discharge devices of the prior art.

The present invention is directed to'the provision of an intrauterine contraceptive device which possess all of the advantages of the device described and claimed -in. my said co-pending application and which has additional contraceptive advantages and increased safety to the uterine walls over said device.

It is an object of the present invention to provide an intra-uterine contraceptive device, of the character de- .scribed,-in which all protruding ends that may bear at a substantial angle against the marginal walls of the uterine cavity and may-thereby cause perforation, ex-

cessive abrasion, muscular'distention and capillary welling withresulting excessive bleeding are substantially eliminated.

It is also, an object of the present invention to provide .anintra-uterine contraceptive device, of the character described, which is capable of more ready conformation'to the varied marginal uterine widths, and to therefore provide a planned and controlledbi-marginal pressure within the uterine cavity.

It is another object of the present invention to provide an intra-uterine contraceptive device which is of ,a shape that conforms or is readily conformable with. a minimum of resistance to theapproximately triangular .shape of the lower uterine segment configuration.

It is a further object of the present invention to pro- .vide an intra-uterine contraceptivedevice, of the character described, which will respond to even minimum contractions of the uterine Wall muscles, especially at the narrower end of the uterine cavity, and will react to such muscular contractions to automatically move the device inwardly within the uterus and upwardly, towards the fundus thereof.

In addition to the use of intra-uterine contraceptive devices for effecting contraception, it has also been the practice to effect contraception by use of various types of pharmaceutical and biological compounds such as compounds that have the characteristic of being spermacidal, hormones that prevent ovulation or nidation,

and other media that has therapeutic value that might be grouped under the term of drugs. Such drugs" are generally administered by oral ingestion, in the form of pills. However, such pills have the disadvantage that they must be regularly and continuously taken in order to be fully effective.

In order to overcome the disadvantage of regular periodic ingestion necessitated by the pills, it has been practiced and tried to provide the same contraceptive effects by implanting the drug subcutaneously, into the tissue of the body in capsule form or as an injected mass or in such packages from which the contraceptive drug is discharged into or absorbed by the tissues, in very small quantities over prolonged periods of time, such as a year or more. This last method of contraceptivepractice, by eliminating the need for regular, periodic dosages, possesses inherent other disadvantages; namely, it is painful at the time of implantation and may form a lump under the skin, which may be continuously painful as long as it remains in the tissues, especially under pressure that may be applied to the site of the implantation. It may also leave permanent scars on the body at the Point of implantation. Further, because it is required, in order to be effective, to have the drugs travel through the entire body system before reaching the effective reproductive mechanism involved, it may produce at least in some individuals, undesirable and sometimes harmful side effects. In such instances an operation to remove the implant or injected mass would be required,with attendant discomfort and danger.

The present invention is, therefore, also directed to the provision of methods and means whereby drugs may be introduced into and retained within the uterine cavity on the surface of the endometrium to be therein slowly discharged for direct action therewithin and for localized absorption by the endometrial surface of the uterine cavity without passing through other parts of the body.

I have found that by using an intra-uterine contraceptive device as a carrier and retention means for a drug package of the character described, such drug" may be introduced into the uterine cavity to be slowly releasedthereinto and absorbed therein in substantially the same manner and to the same degree as if subcutaneously implanted; and that such drug" will remain in situ, within the uterine cavity for as long as the intra-uterine contraceptive device to which it is secured or by which it is carried.

' The foregoing and other objects and advantages of the intra-uterine contraceptive device and methods of the present invention will become more readily apparent to those skilled in the art from the embodiments thereof illustrated in the accompanying drawings and from the description following. It is to be understood,

however, that such embodiments are shown by way of illustration only, to make the principles and practice of the invention more readily comprehensible and without any intent of limiting the invention to the specific details therein shown.

In the drawings:

FIG. 1 is an elevational view of one embodiment of a intra-uterine contraceptive device of the present invention, slightly enlarged over actual size.

FIG. 2 is an end view of the same;

FIG. 3 is a fragmentary, elevational view of one end section of the device of FIG. 1, shown in an intermediate step of adjustment before final disposition of its end elements, to clarify the manner of attaining the shape of the device;

FIG. 4 is a fragmentary view, on a still more enlarged scale of one end of a modified form of the intra-uterine contraceptive device of the present invention, showing more or less schematically, one method of adapting the same for the introduction of contraceptive or other drugs into the uterine cavity;

FIG. 5 is a section taken on line 5-5 of FIG. 4; and

FIG. 6 is a plan view of another embodiment of an intra-uterine contraceptive device of the present invention.

Referring now, in greater detail, to the embodiment of the intra-uterine contraceptive device of the invention illustrated in the drawing, and with particular reference to the embodiment illustrated in FIGS. 1 and 3 thereof, the same is shown to be broadly speaking, an elongated or extended spiral or coil, generally designated as 10, that is flattened to provide a plurality of straight elements or sections 12, joined to one another by resilient, arcuate joints 14, so that alternate elements l2 lie in a common plane spaced from and substantially parallel to, the plane of the other elements. While the spiral 10 may be formed to have the elements 12 in one plane perpendicular to its longitudinal axis and the elements 12 in the other plane at an angle thereto, it is preferred to have all elements 12 disposed at an angle to such axis so that each pair of connected elements, though in different planes, are in V formation relative to one another.

The device 10 may preferably be formed with an even number of elements, such as the twelve elements illustrated in the embodiment of the drawing, so that both elements at each of the ends of the device 10 have their free ends extend in the same direction.

To eliminate protruding ends that may contact the walls of the uterine cavity at an angle, to thereby press against such walls and possibly perforate or abrade such walls, the device 10 may have its outer end which coincides with the free ends unconnected of the end elements 12a, of a width not substantially exceeding and preferably less than the width of the upper end of the device. In the latter instance, there is obtained the tapered shape illustrated in FIGS. 1 and 3, which conforms to the generally triangular shape of the uterine cavity.

One way of attaining the foregoing effect with the device of the present invention is the provision on the free unconnected ends of the end elements 12a of one or two coils, 16, that are arranged preferably to face outwardly, and of trapping the coiled ends of elements 12a against the inner side of the adjacent joint 14 connecting each element 12a connected to element 12a with the adjacent element 12, as clearly shown in FIGS. 1 and 3.

To reduce the resistance of the bottom or outer end of the device to pressure of muscular contraction, so that contraction of the muscles of the uterine walls at its outer narrow end will not tend to discharge the device from the uterus but, rather cause its inward and upward slippage toward the fundus, the end elements 12a and 12h may be longer than the intermediate elements 12, to project past them at the outer end of the device. Such reduced resistance to pressure by the lengthening of the elements 12a and 12h will cause the device to move in the direction of its wider inner upper part under muscular compression of its outer end, just as if the projecting ends of the interengaged elements 12a and 12h were compressed toward one another by the fingers of a hand; in which instance the device would be caused to leap from between the compressing fingers.

The construction of the embodiment of FIG. 1, while responding to muscular pressure at its outer end for resulting inward movement, such movement will, because of the reduced resistance to pressure of such outer end, be gentle and gradual and without sufficient impetus or force to damage the fundus, as might occur, especially in a uterus of smaller size, with other types of devices that have greater resistance to pressure at their outer ends and, when yielding to such pressure, may move inwardly with sufficient force to cause laceration and bleeding of the fundus.

It may here be stated that the central elements 12 may preferably shorten increasing inwardly from both ends, at the bottom of the device, as illustrated, to further reduce resistance to pressure. It may here also be pointed out that the tapered shape of the device in which the narrow end faces the outlet of the uterine cavity and is compressible with lesser resistance to the compressing pressure, affords the advantage that it may be removed from the uterus by instrument, with a minimum risk of damage to its walls, should the withdrawal suture conventionally connected to it break.

A modified form of the device, providing even smoother contact between its ends and the adjacent walls of the uterus is shown in FIGS. 4 and 5 of the drawings, wherein a sleeve, 18, fitted over the interengaged elements and 12h, to close the space between them and to present a flat surface for contact with the end walls of the uterine cavity. Such sleeve will be formed of a material or film that is soft and flexible and is inert to body fluids. The sleeve 18 may, preferably extend above the joint interengaging elements 12a and 12h, as at 180, so that it may overlap at least part of the inner edge of the device, to present a flat and enlarged contact area between that end of the device and the fundus, to protect the latter against injury. If desired, the sleeves 18, at both ends of the device may be formed integrally with the extension 180, to thereby provide an enlarged and flattened contact area between the entire inner edge of the device and the fundus, for even greater protection of the latter, as indicated in FIG. 4 of the drawing.

In the embodiment of FIGS. 4 and 5, a single coil 16 at the end of element 12a will suffice, or the latter may even be cut short at its end; sleeve 18 serving to confine it and adjacent element 12h in close proximity and in parallel relation to one another, and eliminate a protruding end against the wall of the uterine cavity.

In the embodiment of FIG. 6 the principle of the invention of providing an intra-uterine contraceptive device having lesser resistance to pressure at one its outer end or the end facing the uterine outlet when inserted within the uterus, is illustrated in connection with a non-spiral, leaf spring construction in which two substantially parallel elements, 30, are joined by two shorter elements 32, that are connected in V shape arrangement to one another at one end by a resilient joint, such as bight 34'connected at their other ends to the elements 30 by arcuate, resilient joint, 36. The free ends of the elements 30 are inwardly curved to provide eyelets, 38, to which a suture for removal from the uterus may be attached. The two elements 30 may preferably be vertically offset relative to one another, so that, when compressed, the arcuate joint 34 of one element 30 may rest below the arcuate joint of the other, and its eyelet 38 nest below the eyelet of the other, to thereby attain maximum compactness for insertion into theuterus.

The embodiment of FIGS. 4 and 5 is also shown to have provision for the carrying of contraceptive or other drugs, within the uterine cavity. In such embodiment, the means for carrying the drug comprises a pocket, 20, which is shown to be connected, asintegrally, to sleeve 18 on its inwardly facing side.

The pocket 20 may be formed of any material through which the drugs preparation may be gradually, slowly diffused in substantially molecular quantities. Such materials are well known and readily available, and may be of the same kind and type that are used in enclosing such drugs for subcutaneous implantations, as for instance, the materials described in US. Pat. No. 3,279,996 (D. M. Long Jr., et al). It will be understood that pocket 20 may be closed at one end, and provided at its other end with a suitable stopper, 22. It will be understood that where pocket 20 and sleeve or sheath 18 are integrally formed, the sheath 18 will be formed of the same slowly-diffusing membraneous material as pocket 20, and, further, that pocket 20 will be of such width that it may fit in the space between the elements of the two planes, so as not to interfere, in any way, with the compression of the elements for insertion into the uterine cavity. It will also be obvious that the pocket 20 and its drug content will remain in the uterus for as long as the device 10 remains there.

It may here be stated that while the method of introducing contraceptive drugs into the uterus has been described as consisting of placing the drug in a pocket connected with a sleeve fitting over the end elements of the described device, other ways of introducing and retaining such drug" or drug packets into the uterine cavity by means of the contraceptive device may be utilized; as by coating the elements with the drug" or by hooking the drug packet to one or more elements, or placing it in the space between the rows of elements; and further, that such method may be practiced not only with the contraceptive device hereinabove described, but with intra-uterine devices, contraceptive orotherwise, of other types, such as the ones described in my co-pending application and still others that are known in the art or will be introduced and become known in the art.

In addition or serving as a carrier for introducing and retaining contraceptive or therapeutic drug packets into the uterine cavity, the intra-uterine contraceptive device of the present invention, as well as others, may be utilized to alter the environmental characteristics within the uterine cavity in other ways, as by introducing there into metals or metal alloys of different characteristics, capable of creating, with the natural mucous fluids within the uterus, an electrolytic-like effect or field which may have the capability of cellular destruction and thus act as a spermicidal agent or create other desired effects therein. Such metal or metal alloys may be readily associated with or connected to the device by clipping or clamping small sections of the different metals on selected ones of the elements of the device.

This completes the description of the intrauterine contraceptive device of the present invention, as well as the methods and means whereby such devices may be used to introduce into the uterine cavities materials that may alter the environment, electrically and/or chemically, therewithin.

It will be readily apparent that the devices of the present invention present highly improved means for effecting contraception, in that they present a minimum chance of damage to the uterine interior and present a minimum likelihood of being inadvertently discharged from the uterus.

It will also be apparent that by the combining of the intra-uterine contraceptive device with suitable, slowly-diffusing drug packets, the effectiveness of the devices as contraceptives is increased to the maximum, and further presents the opportunity for therapeutic treatment of the uterus walls and other portions of the body system by absorption through the walls of the uterine cavity.

It will be further apparent that numerous variations and modifications may be made in the intra-uterine contraceptive devices of the present invention and in the manner of their association with various kinds of slowly-diffusing drug packets, by anyone skilled in the art, in accordance with the principles of the invention hereinabove set forth, and without the exercise of any inventive ingenuity. I desire, therefore, to be protected for any and all such variations and modifications that may be made in the spirit of the invention and scope of the claims hereto appended.

What I claim is:

1. An intra-uterine contraceptive device, comprising an even-numbered plurality of straight elements, including end elements each terminating in a free end and intermediate elements between said end elements, said elements disposed in a pair of spaced planes with each end of each element in one plane connected to an end of an element in the adjacent plane by an arcuate resilient joint, to form a continuous structure, each element in each plane disposed at an angle to its connected element in the adjacent plane, said elements normally disposed in extended relation to one another and compressible towards one another for insertion into a uterine cavity, each of said end elements formed with a coil at its free end, said coil engaged over the joint connecting the adjacent element in the other plane with the adjacent element of the plane in which said end element lies.

2. An intra-uterine contraceptive device comprising a body formed of an even-numbered plurality of substantially straight elements, said elements including end elements each having a free end and intermediate elements between said end elements, said intermediate elements each connected by each of its ends to an end of an adjacent element in extended angular relation to said adjacent element by an arcuate resilient joint to form a continuous structure, the said elements normally in extended position and compressible toward one another for insertion into a uterine cavity, said end elements having their free ends project past the corresponding ends of said intermediate elements and convergent toward one another in the direction of their free ends, whereby said end elements are adapted to readily, slidably engage against a uterine wall when said device is in extended position within the uterus and said free ends of said end elements are more readily responsive to pressure exerted thereon by muscular contraction at the outer end of the uterus.

3. The device of claim 2, wherein said body is formed of spring wire and has elements disposed in a pair of ends of said end elements thereof. 

1. An intra-uterine contraceptive device, comprising an evennumbered plurality of straight elements, including end elements each terminating in a free end and intermediate elements between said end elements, said elements disposed in a pair of spaced planes with each end of each element in one plane connected to an end of an element in the adjacent plane by an arcuate resilient joint, to form a continuous structure, each element in each plane disposed at an angle to its connected element in the adjacent plane, said elements normally disposed in extended relation to one another and compressible towards one another for insertion into a uterine cavity, each of said end elements formed with a coil at its free end, said coil engaged over the joint connecting the adjacent element in the other plane with the adjacent element of the plane in which said end element lies.
 2. An intra-uterine contraceptive device comprising a body formed of an even-numbered plurality of substantially straight elements, said elements including end elements each having a free end and intermediate elements between said end elements, said intermediate elements each connected by each of its ends to an end of an adjacent element in extended angular relation to said adjacent element by an arcuate resilient joint to form a continuous structure, the said elements normally in extended position and compressible toward one another for insertion into a uterine cavity, said end elements having their free ends project past the corresponding ends of said intermediate elements and convergent toward one another in the direction of their free ends, whereby said end elements are adapted to readily, slidably engage against a uterine wall when said device is in extended position within the uterus and said free ends of said end elements are more readily responsive to pressure exerted thereon by muscular contraction at the outer end of the uterus.
 3. The device of claim 2, wherein said body is formed of spring wire and has elements disposed in a pair of spaced planes with each end of each element in one plane connected to an end of an element in the adjacent plane by said resilient arcuate joint at an angle to said adjacent element to form a flattened spiral.
 4. The intra-uterine device of claim 3, wherein the elements in each plane are also disposed at an angle to the axis transversing them.
 5. The device of claim 4, wherein said intermediate elements are gradually foreshortened from each end of the body towards the center thereof, to thereby form a substantially arcuate edge of the body between said ends of said end elements thereof. 